MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-05 for ORTHOMAX SURGICAL UP-DRAPE DYNJP8303 manufactured by Medline Industries, Inc..
[129649566]
During opening of the sterile drape, it was noticed that there were at least six dead bugs inside of the drape.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081867 |
| MDR Report Key | 8138501 |
| Date Received | 2018-12-05 |
| Date of Report | 2018-12-03 |
| Date of Event | 2018-07-06 |
| Date Added to Maude | 2018-12-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ORTHOMAX SURGICAL UP-DRAPE |
| Generic Name | DRAPE, SURGICAL |
| Product Code | KKX |
| Date Received | 2018-12-05 |
| Returned To Mfg | 2018-07-09 |
| Catalog Number | DYNJP8303 |
| Lot Number | 11017070309 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | NORTHFIELD IL 60093 US 60093 |
| Brand Name | ORTHOMAX SURGICAL UP-DRAPE |
| Generic Name | DRAPE, SURGICAL |
| Product Code | KKX |
| Date Received | 2018-12-05 |
| Returned To Mfg | 2018-07-09 |
| Catalog Number | DYNJP8303 |
| Lot Number | 11017070309 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-05 |